Katalyst CRO
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Principal Regulatory Affairs Specialist
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Katalyst CRO . 5 months ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. Responsibilities
The role requires strong US, EU, China, and international regulatory experience that can be leveraged to help support international expansion. Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams. Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review. Assists with developing and implementing regulatory strategies for new and modified medical devices, as well as for OEM and Contract Manufacturer partnerships. Is a liaison for new business partners to provide regulatory guidance for US, EU, China, and international product registration. Acts as a core member on manufacturing and development teams, providing regulatory feedback and guidance throughout the product development cycle, and coordinating team inputs for submissions. Responsible for preparation and submission of global regulatory applications, as well as internal regulatory file documentation. Reviews device labeling and advertising materials for compliance with global regulations; analyzes and recommends appropriate changes. Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations. Supports and maintains Quality initiatives in accordance with BSC Quality Policy. Continuously assesses ways to improve Quality. Develops and implements departmental and divisional policies and procedures. Supports highly technical or major business segment product lines, special projects or strategic initiatives. Requirements
A minimum of a Bachelor's Degree in a scientific, technical, or related discipline. A minimum of 8 years Regulatory Affairs experience in the medical industry. Prior experience supporting both capital equipment and single-use disposables. Experience with 510(k) submissions, EU MDR, and international regulatory registrations. Working knowledge of FDA, EU, and international regulations for medical devices. Ability to interpret global regulations and standards. Understanding of product development, design control, and quality system regulations. Knowledge of regulations for clinical trials. Experience supporting contract manufacturing and OEM products. Ability to manage multiple projects simultaneously. Proficiency with Microsoft Office. Strong research, analytical, written, and oral communication skills. Ability to work independently with minimal supervision. Additional Details
Seniority level: Mid-Senior level Employment type: Contract Job function: Legal Industries: Pharmaceutical Manufacturing
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Principal Regulatory Affairs Specialist
role at
Katalyst CRO . 5 months ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. Responsibilities
The role requires strong US, EU, China, and international regulatory experience that can be leveraged to help support international expansion. Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams. Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review. Assists with developing and implementing regulatory strategies for new and modified medical devices, as well as for OEM and Contract Manufacturer partnerships. Is a liaison for new business partners to provide regulatory guidance for US, EU, China, and international product registration. Acts as a core member on manufacturing and development teams, providing regulatory feedback and guidance throughout the product development cycle, and coordinating team inputs for submissions. Responsible for preparation and submission of global regulatory applications, as well as internal regulatory file documentation. Reviews device labeling and advertising materials for compliance with global regulations; analyzes and recommends appropriate changes. Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations. Supports and maintains Quality initiatives in accordance with BSC Quality Policy. Continuously assesses ways to improve Quality. Develops and implements departmental and divisional policies and procedures. Supports highly technical or major business segment product lines, special projects or strategic initiatives. Requirements
A minimum of a Bachelor's Degree in a scientific, technical, or related discipline. A minimum of 8 years Regulatory Affairs experience in the medical industry. Prior experience supporting both capital equipment and single-use disposables. Experience with 510(k) submissions, EU MDR, and international regulatory registrations. Working knowledge of FDA, EU, and international regulations for medical devices. Ability to interpret global regulations and standards. Understanding of product development, design control, and quality system regulations. Knowledge of regulations for clinical trials. Experience supporting contract manufacturing and OEM products. Ability to manage multiple projects simultaneously. Proficiency with Microsoft Office. Strong research, analytical, written, and oral communication skills. Ability to work independently with minimal supervision. Additional Details
Seniority level: Mid-Senior level Employment type: Contract Job function: Legal Industries: Pharmaceutical Manufacturing
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